Mechanistic and Pharmacokinetic Studies of Classical Chinese Formula Xiao Chai Hu Tang (XCHT) Against Irinotecan-Induced Gut Toxicities(Clinical Study Part:Randomized Controlled Trial)

Randomized double-blind placebo-controlled trial (RCT) study, to determine the impact of XCHT on irinotecan-induced severe delayed-onset diarrhea (SDOD), and to determine the feasibility of using plasma raloxifene-4'-glucuronide as a probe for intestinal UGT activity.

Start Date08 Mar 2024

Sponsor / Collaborator

Guangzhou University of Chinese Medicine

[+1]

CTR20213368

/ CompletedNot Applicable

盐酸雷洛昔芬片在健康成年受试者中单次空腹及高脂餐后口服给药的随机、开放、两周期、两序列、交叉设计生物等效性试验方案

[Translation] A randomized, open-label, two-period, two-sequence, crossover bioequivalence study of raloxifene hydrochloride tablets in healthy adult subjects after single oral administration on an empty stomach or after a high-fat meal

研究重庆圣华曦药业股份有限公司生产的盐酸雷洛昔芬片（规格：60mg）在中国健康受试者中空腹及高脂餐后以口服途径单次给药的药代动力学特征，并以Eli Lilly Nederland B.V持有Lilly,S.A.生产的盐酸雷洛昔芬片（商品名：EVISTA®；规格：60mg）为参比制剂，进行生物等效性评价。考察盐酸雷洛昔芬片受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

The pharmacokinetic characteristics of raloxifene hydrochloride tablets (specification: 60 mg) produced by Chongqing Shenghuaxi Pharmaceutical Co., Ltd. were studied after a single oral administration in Chinese healthy subjects on an empty stomach and after a high-fat meal. The bioequivalence evaluation was performed using raloxifene hydrochloride tablets (trade name: EVISTA®; specification: 60 mg) produced by Lilly, S.A. owned by Eli Lilly Nederland B.V. as the reference preparation. The safety of the test preparation and reference preparation of raloxifene hydrochloride tablets in healthy subjects was investigated.

Start Date21 Dec 2021

Sponsor / Collaborator

Chongqing Shenghuaxi Pharmaceutical Co. Ltd.

EUCTR2021-002476-39-IT

/ Not yet recruitingPhase 4

Prospective study to evaluate the effects of Raloxifene therapy on SARS-CoV-2 immunity after COVID-19 vaccination - RALOXIVAXI

Start Date29 Jul 2021

Sponsor / Collaborator-

100 Clinical Results associated with Raloxifene Hydrochloride

100 Translational Medicine associated with Raloxifene Hydrochloride

100 Patents (Medical) associated with Raloxifene Hydrochloride

5,678

Literatures (Medical) associated with Raloxifene Hydrochloride

01 May 2025·BONE

Combined Romosozumab and Raloxifene treatment targets impaired bone quality in a male murine model of diabetic kidney disease

Article

Author: Kohler, Rachel ; Metzger, Corinne E ; Wallace, Joseph M ; Segvich, Dyann M ; Reul, Olivia ; Allen, Matthew R

Comorbid diabetes and chronic kidney disease create a complex disease state with multi-faceted impacts on bone health, primarily reduced bone mass and tissue quality. To reduce fracture risk in this growing population, interventions are needed that target both bone mass and quality. Romosozumab (Romo) is an FDA-approved sclerostin inhibitor that has been shown to increase bone mass and strength in a murine model of combined diabetes and CKD (DKD), while Raloxifene (RAL) is a mild anti-resorptive used to treat osteoporosis that has also been shown to increase bone mechanical properties by increasing bone bound water content. We aimed to test whether combined RAL and Romo treatment could improve bone quality in our murine model of DKD more than either treatment alone. Using a previously established streptozotocin- and adenine-diet-induced model, male, C57BL/6J mice were randomly divided into four treatment groups and given daily subcutaneous injections of 100 μL vehicle (phosphorus buffered saline, PBS) or 0.5 mg/kg RAL. In addition, two groups were also given a weekly dose of Romo (10 mg/kg). Overall, Romo increased whole-bone strength and RAL improved tissue-level mechanical properties. Combined RAL-Romo treatment led to significantly higher cortical and trabecular bone mass compared to untreated controls. These morphological improvements created corresponding improvements in cortical bending strength and vertebral trabecular compression strength. These results suggest that combined RAL-Romo treatment provides both mass and quality improvements to DKD bone.

01 Mar 2025·JOURNAL OF HAZARDOUS MATERIALS

A genetically encoded fluorescent whole-cell biosensor for real-time detecting estrogenic activities in water samples

Article

Author: Chen, Ling ; Yang, Junyi ; Ren, Hongqiang ; Yuan, Shengjie ; He, Ruonan ; Wu, Bing

Real-time monitoring of estrogenic activity in the aquatic environment is a challenging task. Current biosensors face difficulties due to their limited response speed and environmental tolerance, especially for detecting wastewater, the major source of estrogenic compounds in aquatic environments. To address these difficulties, this study developed a single fluorescent protein (FP) -based whole-cell bacterial biosensor named ER-Light, which was achieved by inserting the sensing domain of the estrogen receptor (ER) into the FP Citrine and expressing it in the periplasm of Escherichia coli. As designed, ER-Light enables the detection of net estrogenic activity in mixtures, represented by estradiol equivalent concentration (EEQ). ER-Light detects EEQ in 40 s with a detection limit of 4.55 × 10^-7 μM and a maximum working range of 1.1 × 10^-4 μM, demonstrating sufficient response speed, sensitivity, and working range. In addition, the ER-Light can survive and tolerate wastewater effluent. Satisfactory recoveries (91.0 % to 102.1 %) eliminated concerns about the matrix effect of wastewater. EEQs (Not detected-2.9 ×10^-5 µM) measured by ER-Light from the effluent of 9 wastewater treatment plants validate its practicality in detecting wastewater. This is the first attempt to integrate ER into FP-based biosensors for environment monitoring. Our findings provide valuable design rules for real-time detection of bioactivity effects in the environment, contributing to the safeguarding of ecological and human health.

01 Mar 2025·MOLECULAR NEUROBIOLOGY

Raloxifene Prevents Chemically-Induced Ferroptotic Neuronal Death In Vitro and In Vivo

Article

Author: Yang, Yong Xiao ; Liao, Lixi ; Wang, Yifan ; Zhu, Bao Ting ; Hao, Xiangyu ; Hou, Ming-Jie ; Wang, Ying-Hua

Ferroptosis, a regulated form of cell death characterized by excessive iron-dependent lipid peroxidation, can be readily induced in cultured cells by chemicals such as erastin and RSL3. Protein disulfide isomerase (PDI) has been identified as an upstream mediator of chemically induced ferroptosis and also a target for ferroptosis protection. In this study, we discovered that raloxifene (RAL), a selective estrogen receptor modulator known for its neuroprotective actions in humans, can effectively inhibit PDI function and provide robust protection against chemically induced ferroptosis in cultured HT22 neuronal cells. Specifically, RAL can bind directly to PDI both in vitro and in intact neuronal cells and inhibit its catalytic activity. Computational modeling analysis reveals that RAL can tightly bind to PDI through forming a hydrogen bond with its His256 residue, and biochemical analysis further shows that when PDI's His256 is mutated to Ala256, RAL loses its inhibition of PDI's catalytic activity. This inhibition of PDI by RAL significantly reduces the dimerization of both the inducible and neuronal nitric oxide synthases and the accumulation of nitric oxide, both of which have recently been shown to play a crucial role in mediating chemically induced ferroptosis through subsequent induction of ROS and lipid-ROS accumulation. In vivo behavioral analysis shows that mice treated with RAL are strongly protected against kainic acid-induced memory deficits and hippocampal neuronal damage. In conclusion, this study demonstrates that RAL is a potent inhibitor of PDI and can effectively prevent chemically induced ferroptosis in hippocampal neurons both in vitro and in vivo. These findings offer a novel estrogen receptor-independent mechanism for RAL's neuroprotective actions in animal models and humans.

News (Medical) associated with Raloxifene Hydrochloride

10 Sep 2024

·www.drugs.com

Review Weighs Treatments for Genitourinary Symptoms of Menopause

TUESDAY, Sept. 10, 2024 -- Vaginal estrogen, vaginal dehydroepiandrosterone (DHEA), oral ospemifene, and vaginal moisturizers may be beneficial for some genitourinary symptoms of menopause (GSM), according to a review published online Sept. 10 in the Annals of Internal Medicine . Elisheva R. Danan, M.D., M.P.H., from the University of Minnesota in Minneapolis, and colleagues examined the effectiveness and harms of vaginal estrogen, nonestrogen hormone therapies, and vaginal moisturizers for treatment of GSM in a systematic review of randomized controlled trials (RCTs). A total of 46 RCTs assessing vaginal estrogen, nonestrogen hormones, vaginal moisturizers, or multiple interventions were identified from 11,993 citations. The researchers found that vaginal estrogen may improve vulvovaginal dryness, dyspareunia , the most bothersome symptom, and treatment satisfaction compared with placebo or no treatment. Vaginal DHEA may improve dryness, dyspareunia, and distress, bother, or interference from genitourinary symptoms compared with placebo; oral ospemifene may improve dryness, dyspareunia, and treatment satisfaction; and dryness may also be improved by vaginal moisturizers (all low certainty of evidence [COE]). No benefit or uncertain effects (low and very low COE, respectively) may be provided by vaginal testosterone, systemic DHEA, vaginal oxytocin, and oral raloxifene or bazedoxifene. Reporting was limited by studies of short duration that were insufficiently powered to assess infrequent serious harms. "Future studies would be strengthened by standard definitions of symptoms and uniform diagnostic criteria for GSM, a common set of validated outcome measures and reporting standards, and attention to clinically relevant patient populations and intervention comparisons," the authors write.

Clinical Result

24 May 2023

·www.biospace.com

New Data Reveal Role of SARS-Cov-2 Spike Protein in Covid-19 Associated Coagulopathy

Unprecedented comprehension of the interaction between Spike and the Human Estrogen Receptor Alfa provides insights for a new generation of anti SARS-CoV-2 and pan-Coronavirus vaccines Italian and US researchers have revealed how the SARS-CoV-2 Spike protein interacts with human Estrogen Receptor-α (ERα) leading to severe coagulopathy observed in COVID-19 patients. The new data - published in Nature’s Signal Transduction and Targeted Therapy - shows that point mutations in the sequence of SARS-CoV-2 Spike (S)-protein eliminate its pro-coagulation effect without compromising immunogenicity. The findings provide actionable insights for designing vaccines lacking of estrogen-receptor mediated side effects for all coronavirus strains and other viral infections. MILAN & SAN MATEO, Calif.--(BUSINESS WIRE)-- Dompé farmaceutici announced today new peer-reviewed data demonstrating that small changes in the SARS-CoV-2 Spike (S)-protein sequence can eliminate its effect in inducing coagulation1. The tendency for the Spike protein to stimulate inflammatory and coagulation has been implicated in coagulopathy observed in the lungs, heart and kidneys of COVID-19 patients with a similar and extremely rare effects observed in a minority of patients who received COVID-19 vaccines. This press release features multimedia. View the full release here: Framework Dompé farmaceutici Biotech production (Photo: Business Wire) Data stemmed from the EXSCALATE supercomputing calculation predicted a potential function of Spike (S) as a co-factor for human ERα nuclear signalling. This interaction is mediated by a nuclear receptor co-regulator (NRC) LXD-like motif present on the viral protein S2 subunit, and the activation function 2 (AF-2) region on ERα2. This work builds on other recent studies3,4 showing that coagulopathy is clearly associated with the interaction of the SARS-CoV-2 Spike (S) protein with the human Erα. While circulating estrogens play a protective role by regulating the immune response to infection, modulation of ERα signalling in SARS-CoV-2-infected lung tissue stimulates proinflammatory signals leading to hypertrophy, vasoconstriction, and vessel obstruction. In the new article the scientists of the italo-american collaboration (encompassing Centro Cardiologico Monzino in Italy and the National Institute on Drug Abuse and the Johns Hopkins School of Medicine in the US) demonstrated that the interaction between the Spike protein and ERα leads to an increase in tissue factor (TF) and the overall pro-coagulation activity in two human endothelial cell lines. The results were further validated by overexpressing S-protein in mice. This pro-coagulative function of Spike in vitro and in vivo, was abolished or strongly reduced by the variants of the Spike proteins carrying mutations in the interaction domain with ERα (as predicted by EXSCALATE). “The value and benefits of vaccines in countering the COVID-19 pandemic remain unquestionable and overwhelming compared to the risks associated with infection from SARS-CoV-2” underscores Maurizio Pesce, a research Group Leader at the Monzino Cardiology Center in Milan, Italy, and initiator of the study in 2021 together with the leading Silvia Barbieri, another research Group Leader at Monzino, “We hope that our findings will be considered in the development of the next generation of vaccines reducing the residual side effects and risks. Our data also unravel a new function of the viral protein in direct regulation of thrombosis associated factors. This has general implications not only for COVID-19, but for other viral infections altering the coagulation pro patients”. “This continuing research is critical to understand the pathogenetic mechanisms associated with SARS-CoV2 infection and causal mechanisms of some rare COVID-19 vaccine side effects,” says Dompé farmaceutici Chief Scientific Officer Marcello Allegretti “Ongoing expanding data is revealing a well-conserved region with the same characteristics of the LXD-like motif present on the viral protein S2 subunit, also in other Coronaviruses. This evidence could open new scenarios in ‘pan-Coronavirus’ vaccination. We are excited to identify a path toward further refinement strategies to enable even more powerful benefits through future vaccination and booster initiatives”. ____________________________________________________________________________________ About Dompé Dompé is a private, rapidly scaling international biopharmaceutical company founded in Milan, Italy, with a 130-year legacy of medical innovation. The R&D department of the company is anchored by EXSCALATE, a structure-based virtual screening platform developed in-house that leverages one of the most powerful supercomputing and artificial intelligence platforms in the world. Today, Dompé employs more than 800 employees worldwide and maintains a US commercial operations hub in the San Francisco Bay Area as well as an R&D presence in Boston. Forward Looking Statements This press release refers to certain information that may not coincide with expected future results. Dompé firmly believes in the soundness and reasonableness of the concepts expressed. However, some of the information is subject to a certain degree of indetermination in relation to its research and development activities and the necessary verifications to be performed by regulatory bodies. Therefore, as of today, Dompé cannot guarantee that the expected results will be consistent with the information provided above. 1. SS Barbieri et al. Relevance of the viral Spike protein/cellular Estrogen Receptor-α interaction for endothelial-based coagulopathy induced by SARS-CoV-2 - Signal Transduction and Targeted Therapy - 2. Allegretti, M. et al. Repurposing the estrogen receptor modulator raloxifene to treat SARS-CoV-2 370 infection. Cell Death Differ. 29, 156-166 (2022). 371 - 3. Wilcox et al. Sex Differences in Thrombosis and Mortality in Patients Hospitalized for COVID-19, Am J Cardiol. 2022 May 1; 170: 112–117 - 4. Science Advances - The SARS-CoV-2 spike protein binds and modulates estrogen receptors - eadd4150 (2022) 30 November 2022 -

Vaccine

24 May 2023

·www.dompe.com

New Data Reveal Role of SARS-Cov-2 Spike protein in Covid-19 associated coagulopathy

Italian and US researchers have revealed how the SARS-CoV-2 Spike protein interacts with human Estrogen Receptor-α (ERα) leading to severe coagulopathy observed in COVID-19 patients. Italian and US researchers have revealed how the SARS-CoV-2 Spike protein interacts with human Estrogen Receptor-α (ERα) leading to severe coagulopathy observed in COVID-19 patients. The new data - published in Nature’s Signal Transduction and Targeted Therapy - shows that point mutations in the sequence of SARS-CoV-2 Spike (S)-protein eliminate its pro-coagulation effect without compromising immunogenicity. The findings provide actionable insights for designing vaccines lacking of estrogen-receptor mediated side effects for all coronavirus strains and other viral infections. The new data - published in Nature’s Signal Transduction and Targeted Therapy - shows that point mutations in the sequence of SARS-CoV-2 Spike (S)-protein eliminate its pro-coagulation effect without compromising immunogenicity. The findings provide actionable insights for designing vaccines lacking of estrogen-receptor mediated side effects for all coronavirus strains and other viral infections. MILAN, Italy and SAN MATEO, Calif. | 22 May, 2023 - Dompé farmaceutici announced today new peer-reviewed data demonstrating that small changes in the SARS-CoV-2 Spike (S)-protein sequence can eliminate its effect in inducing coagulation [1]. The tendency for the Spike protein to stimulate inflammatory and coagulation has been implicated in coagulopathy observed in the lungs, heart and kidneys of COVID-19 patients with a similar and extremely rare effects observed in a minority of patients who received COVID-19 vaccines. Data stemmed from the EXSCALATE supercomputing calculation predicted a potential function of Spike (S) as a co-factor for human ERα nuclear signalling. This interaction is mediated by a nuclear receptor co-regulator (NRC) LXD-like motif present on the viral protein S2 subunit, and the activation function 2 (AF-2) region on ERα [2]. This work builds on other recent studies [3], [4] showing that coagulopathy is clearly associated with the interaction of the SARS-CoV-2 Spike (S) protein with the human Erα. While circulating estrogens play a protective role by regulating the immune response to infection, modulation of ERα signalling in SARS-CoV-2-infected lung tissue stimulates proinflammatory signals leading to hypertrophy, vasoconstriction, and vessel obstruction. In the new article the scientists of the italo-american collaboration (encompassing Centro Cardiologico Monzino in Italy and the National Institute on Drug Abuse and the Johns Hopkins School of Medicine in the US) demonstrated that the interaction between the Spike protein and ERα leads to an increase in tissue factor (TF) and the overall pro-coagulation activity in two human endothelial cell lines. The results were further validated by overexpressing S-protein in mice. This pro-coagulative function of Spike in vitro and in vivo, was abolished or strongly reduced by the variants of the Spike proteins carrying mutations in the interaction domain with ERα (as predicted by EXSCALATE). “The value and benefits of vaccines in countering the COVID-19 pandemic remain unquestionable and overwhelming compared to the risks associated with infection from SARS-CoV-2” underscores Maurizio Pesce, a research Group Leader at the Monzino Cardiology Center in Milan, Italy, and initiator of the study in 2021 together with the leading Silvia Barbieri, another research Group Leader at Monzino, “We hope that our findings will be considered in the development of the next generation of vaccines reducing the residual side effects and risks. Our data also unravel a new function of the viral protein in direct regulation of thrombosis associated factors. This has general implications not only for COVID-19, but for other viral infections altering the coagulation profile of patients”. “This continuing research is critical to understand the pathogenetic mechanisms associated with SARS-CoV2 infection and causal mechanisms of some rare COVID-19 vaccine side effects,” says Dompé farmaceutici Chief Scientific Officer Marcello Allegretti “Ongoing expanding data is revealing a well-conserved region with the same characteristics of the LXD-like motif present on the viral protein S2 subunit, also in other Coronaviruses. This evidence could open new scenarios in ‘pan-Coronavirus’ vaccination. We are excited to identify a path toward further refinement strategies to enable even more powerful benefits through future vaccination and booster initiatives”. [1] SS Barbieri et al. Relevance of the viral Spike protein/cellular Estrogen Receptor-α interaction for endothelial-based coagulopathy induced by SARS-CoV-2 - Signal Transduction and Targeted Therapy [2] Allegretti, M. et al. Repurposing the estrogen receptor modulator raloxifene to treat SARS-CoV-2 370 infection. Cell Death Differ. 29, 156-166 (2022). 371 [3] Wilcox et al. Sex Differences in Thrombosis and Mortality in Patients Hospitalized for COVID-19, Am J Cardiol. 2022 May 1; 170: 112–117 [4] Science Advances - The SARS-CoV-2 spike protein binds and modulates estrogen receptors - eadd4150 (2022) 30 November 2022

Vaccine

100 Deals associated with Raloxifene Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D02217	Raloxifene Hydrochloride	G03XC01	DB00481

R&D Status

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10 top approved records.

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Indication	Country/Location	Organization	Date
Breast Cancer	United States	Eli Lilly & Co.	13 Sep 2007
Osteoporosis, Postmenopausal	United States	Eli Lilly & Co.	09 Dec 1997

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	France	Dompe Farmaceutici SpA	22 Jan 2021
COVID-19	Phase 3	Italy	Dompe Farmaceutici SpA	22 Jan 2021
COVID-19	Phase 3	Spain	Dompe Farmaceutici SpA	22 Jan 2021
Cardiovascular Diseases	Phase 3	United States	Eli Lilly & Co.	01 Jun 1998
Invasive Mammary Carcinoma	Phase 3	United States	Eli Lilly & Co.	01 Jun 1998
Hemorrhagic Fever, Ebola	Phase 2	Italy	Dompe Farmaceutici SpA	30 Jan 2022
Hepatitis B	Phase 2	Italy	Dompe Farmaceutici SpA	30 Jan 2022
Hepatitis C, Chronic	Phase 2	Italy	Dompe Farmaceutici SpA	30 Jan 2022
Zika Virus Infection	Phase 2	Italy	Dompe Farmaceutici SpA	30 Jan 2022
Hot Flashes	Phase 2	United States	Eli Lilly & Co.	01 Feb 2002

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ODP119 (ENDO2022)	Not Applicable	Osteoporosis, Postmenopausal	66	Raloxifene users	bbgrlvbzmk(kbhjqfeamw) = ecfveufmzp qanaiioivr (wbkvawxjru )	Positive	01 Nov 2022
DDW2022	Not Applicable	Osteoporosis, Postmenopausal	-	Raloxifene	kjrppabaxj(nealxhnuzy): OR = 1.854 (95% CI, 1.643 - 2.092) View more	-	24 May 2022
				No Raloxifene
DDW2022	Not Applicable	Osteoporosis, Postmenopausal	-	Raloxifene	eohrxpgkct(ywruzcojrd): OR = 1.854 (95% CI, 1.643 - 2.092) View more	-	24 May 2022
				No Raloxifene
DDW2022	Not Applicable	Osteoporosis, Postmenopausal	-	Raloxifene	ttdwnyhpcl(yrfvesmlyr): OR = 1.854 (95% CI, 1.643 - 2.092) View more	-	24 May 2022
				No Raloxifene
DDW2022	Not Applicable	Osteoporosis, Postmenopausal	-	Raloxifene	repjgbxtsq(ghlmmlduzv): OR = 1.854 (95% CI, 1.643 - 2.092) View more	Negative	24 May 2022
				No Raloxifene
DDW2022	Not Applicable	Osteoporosis, Postmenopausal	-	Raloxifene	nhvqveveen(msgakcmowl): OR = 1.854 (95% CI, 1.643 - 2.092) View more	Negative	24 May 2022
				No Raloxifene
P0903 (ERA2020)	Not Applicable	Chronic Kidney Diseases	39,128	Osteoporosis medications (bisphosphonates, raloxifene, teriparatide, or denosumab)	dwcvtjdhxd(wafzhggkpx) = lqdprszmof atixxrarpk (kflatlfaod ) View more	Negative	06 Jun 2020
2020 ARVO Annual Meeting (ARVO2020)	Phase 2	Brain Injuries, Traumatic	-	Raloxifene 5 mg/kg	fhgvgrllkx(wtgioazlgq) = reduced or eliminated zdvidvlxzl (zoumlatedt ) View more	Positive	01 Jun 2020
				Raloxifene 10 mg/kg
NCT00687102 (Co-STAR, CTgov)	Phase 3	Cognition	1,498	tamoxifen (Star Participants Assigned to Tamoxifen)	uqjygzcktm(azbejnxeyw) = yxmuroitrl fwvtcaoscu (gtioqcgnux, 0.34) View more	-	23 Jan 2018
				raloxifene (Star Participants Assigned to Raloxifene)	uqjygzcktm(azbejnxeyw) = yoiufusieo fwvtcaoscu (gtioqcgnux, 0.32) View more

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Raloxifene Hydrochloride

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